Authority & regime
- Competent authority
- Department of Health Infrastructure and Medical Devices (Cục Hạ tầng và Thiết bị y tế, IMDA) under the Ministry of Health is the competent authority for medical devices; from 22/11/2025 Cir…
- Procedures decentralized to IMDA
- IMDA handles: new Class C/D circulation numbers (Art. 32/32a Decree 98 as amended), post issuance examination (para 3 4 Art. 32), batch suspension (para 3 Art. 34), batch recall (para 4 Art…


